On May 16, OEHHA issued its fifth iteration of the revised Proposition 65 warning regulations. As these changes largely seek to clarify existing language in the proposed regulations since the prior revision in March, we have a pretty good idea of what the final regulations will look like (although OEHHA does reserve the right to make additional changes).

Once the final regulatory text is published, OEHHA will also publish its “Final Statement of Reasons,” which responds to public comments on the initial proposed regulation and interim revisions and explains changes that OEHHA did or did not make in response to those comments. This document should provide helpful insight into the application of the regulation and strategies for compliance. We will provide our analysis of the final regulation and FSOR once published.

Safe harbor warning language – consumer products

We expect the final safe harbor warning language for consumer products to be the following where the warning is not being provided on the label of the product:

WARNING: This product can expose you to chemicals including [name of chemical], which [is/are] known to the State of California to cause [cancer]/[birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov.

The warning will require identification of at least one listed chemical. If the exposure requires a warning for both cancer and birth defects, the chemical identified must be known to cause both, or the warning must identify two listed chemicals – one for each exposure type.

On label warnings are much more abbreviated, and do not require the identification of a specific chemical:

WARNING: [Cancer/Reproductive Harm/Cancer and Reproductive Harm] – www.P65Warnings.ca.gov

Safe harbor warning language – environmental

The warning language for environmental exposures in physical locations has been revised to require even greater specificity then that for products. The provider of the warning for an exposure in a physical location has to identify at least one source of the exposure within the area. Rather than a generic warning that “[e]ntering this area can expose you to chemicals…,” the provider of the warning will now have to provide a warning such as “vehicle exhaust in this area can expose you to chemicals…”

Existing inventories

We expect a two-year delay before the new warning requirements become effective and an exemption for products manufactured before the effective date of the proposed regulation that have a warning that is currently compliant. Also, products subject to an existing consent judgment are deemed to comply with Proposition 65 if they comply with the consent judgment.

Supplemental information

The regulation will likely limit supplemental information in warnings to only the source of exposure and ways to avoid or reduce exposure. There is considerable uncertainty as to what “supplemental information” is, and whether this provision violates the First Amendment by prohibiting true and non-misleading speech.

Manufacturer responsibility

Despite Proposition 65 requiring that OEHHA aim to minimize the burden of compliance on retailers, to the extent practicable, we expect the final regulation to state that manufacturers, producers, packagers, importers, suppliers, or distributors can only comply by placing a compliant warning on the product or provides written notice to the “authorized agent for the retail seller” that includes:

  • An express statement that the product may result in an exposure to listed chemicals;
  • Specific identification of the product; and
  • All necessary warning materials (labels, labeling, shelf signs or tags, and warning language for internet sales).

The retailer/authorized agent must confirm receipt electronically or in writing, and the manufacturer, producer, packager, importer, supplier, or distributor must reconfirm written notice within the first six months during the first year, and then annually after that.

The manufacturer, producer, packager, importer, supplier, or distributor must also provide the retail seller with additional notice within 90 days if a new chemical name or endpoint is included in the warning on a product (for example, cancer or reproductive toxicity).

The regulation states that a retailer is responsible for providing the warning if the manufacturer, producer, packager, importer, supplier, or distributor complies with these provisions. But we expect the final regulation to allow retailers to opt out of this process in its contracts with its suppliers.

Retailer obligations

In addition to the process in the previous section, a retailers will be directly responsible for compliance if:

  • It is a private label product
  • The retailer knowingly and intentionally introduces a listed chemical into the product, or caused a listed chemical to be created in the product;
  • The retailer covers, obscures or alters a warning label already affixed to the product;
  • The retailer has “actual knowledge” of the potential product exposure requiring the warning, and the manufacturer, distributor, importer, or packager are all (a) exempt from Prop 65, and/or (b) foreign entities with no agent for service of process.

OEHHA has clarified in this proposal that retailers will be required to provide internet warnings for products sold online, even if they are labeled with a Proposition 65 warning, but requires manufacturers to identify the products that require an online warning and the language to be provided.

“Actual knowledge” for retailers

We expect the final regulation to define “actual knowledge” as “specific knowledge of the consumer product exposure received by the retail seller from any reliable source.” A Prop 65 60-day notice from a plaintiff will only constitute “actual knowledge” five business days after a retailer receives it. The retailer will have five business days to either provide a warning or remove the product from sale in California after receiving the 60-day notice, if the retailer has no other actual knowledge of a product exposure

While this is an improvement over the initially proposed two day grace period, five business days will probably still result in a logistical fire drill every time a retailer receives a notice, to determine whether the manufacturer or supplier is exempt or overseas, and if so, whether and how to pull a product or provide a warning within that time period.